The following data is part of a premarket notification filed by Bicon, Llc with the FDA for Trinia.
Device ID | K133608 |
510k Number | K133608 |
Device Name: | TRINIA |
Classification | Material, Tooth Shade, Resin |
Applicant | BICON, LLC 501 ARBORWAY Boston, MA 02130 |
Contact | Richard Wu |
Correspondent | Richard Wu BICON, LLC 501 ARBORWAY Boston, MA 02130 |
Product Code | EBF |
Subsequent Product Code | EBG |
Subsequent Product Code | EBI |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-11-25 |
Decision Date | 2014-03-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00813110020444 | K133608 | 000 |
00813110020420 | K133608 | 000 |
00813110020406 | K133608 | 000 |
00813110020147 | K133608 | 000 |
00813110020093 | K133608 | 000 |
00813110020048 | K133608 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TRINIA 97644720 not registered Live/Pending |
Bicon, LLC 2022-10-24 |
TRINIA 86770204 5121867 Live/Registered |
Bicon, LLC 2015-09-28 |
TRINIA 85601193 4210175 Live/Registered |
Bicon, LLC 2012-04-18 |